AMPLATZER Duct Occluder II Clinical Study
Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Patent Ductus Arteriosus
Intervention
AMPLATZER Duct Occluder II
Location
Children's Hospital and Health Center
San Diego
California
United States
92123
Status
Active, not recruiting
Source
AGA Medical Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00713700
- Information obtained from ClinicalTrials.gov on July 16, 2012
Medical and Biotech [MESH] Definitions
Ductus Arteriosus, Patent
A congenital heart defect characterized by the persistent opening of fetal DUCTUS ARTERIOSUS that connects the PULMONARY ARTERY to the descending aorta (AORTA, DESCENDING) allowing unoxygenated blood to bypass the lung and flow to the PLACENTA. Normally, the ductus is closed shortly after birth.
Persistent Fetal Circulation Syndrome
A syndrome of persistent PULMONARY HYPERTENSION in the newborn infant (INFANT, NEWBORN) without demonstrable HEART DISEASES. This neonatal condition can be caused by severe pulmonary vasoconstriction (reactive type), hypertrophy of pulmonary arterial muscle (hypertrophic type), or abnormally developed pulmonary arterioles (hypoplastic type). The newborn patient exhibits CYANOSIS and ACIDOSIS due to the persistence of fetal circulatory pattern of right-to-left shunting of blood through a patent ductus arteriosus (DUCTUS ARTERIOSUS, PATENT) and at times a patent foramen ovale (FORAMEN OVALE, PATENT).
Ductus Arteriosus
A fetal blood vessel connecting the pulmonary artery with the descending aorta.
Saccule And Utricle
Two membranous sacs within the vestibular labyrinth of the INNER EAR. The saccule communicates with COCHLEAR DUCT through the ductus reuniens, and communicates with utricle through the utriculosaccular duct from which the ENDOLYMPHATIC DUCT arises. The utricle and saccule have sensory areas (acoustic maculae) which are innervated by the VESTIBULAR NERVE.
Hypoplastic Left Heart Syndrome
A condition caused by underdevelopment of the whole left half of the heart. It is characterized by hypoplasia of the left cardiac chambers (HEART ATRIUM; HEART VENTRICLE), the AORTA, the AORTIC VALVE, and the MITRAL VALVE. Severe symptoms appear in early infancy when DUCTUS ARTERIOSUS closes.
Clinical Trials
The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature bab...
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and...
Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large d...
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
Patent Ductus Arteriosus (PDA) Screening Trial
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of...
PubMed Articles
Residual patent ductus arteriosus (PDA) after surgical ligation is not common, but the anatomy of the residual duct may be distorted by the surgical ligation resulting in a difficult transcatheter clo...
The transcatheter closure of patent ductus arteriosus (PDA) may cause more complications in small children. Amplatzer (St. Jude Medical, Plymouth, MN) has produces three types of devices for ductal oc...
The new Amplatzer duct occluder II: when is its use advantageous?
OBJECTIVES: To determine the safety and efficacy of the Amplatzer duct occluder and the Amplatzer duct occluder II in different types of arterial ducts, and to determine in which types of ducts the us...
We describe a case of transcatheter occlusion of a large and tortuose coronary artery fistula in an 8-year-old girl. During 2.5 years' of follow-up, she had no complaints and developed normally. This...
Estimation of patent ductus arteriosus diameters by colour Doppler echocardiography in children.
OBJECTIVE: To investigate whether accurate estimation of the diameter of the patent ductus arteriosus can be obtained by colour Doppler echocardiography. METHODS: The minimum and maximum diameters of...
